Certis Pharma was established in 2025 by an experienced team with a track record in projects related to the manufacture of medicinal products, registration, and administrative law.
What sets us apart from other companies is our individual approach to each client. We ensure that every issue reported is entrusted to the best specialist, who will not only help find an effective solution, but also support you in building a stable and secure vision for the future of your business.
Although we are a young organization, it is made up of experts with over 20 years of experience in the pharmaceutical sector. This allows us to combine a fresh perspective and innovative approach with a deep understanding of the market and its regulations.
From the very first months of our operation, we have gained the trust of many companies that contacted us via the form on our website and decided to establish long-term cooperation. For us, this is the best proof that our individual approach, professionalism, and commitment build lasting relationships based on trust and mutual development, which work well in a real work environment!
Our team consists of professionals with many years of experience in the pharmaceutical industry. Our colleagues from around the globe are trusted advisors to the world’s leading cannabis producers.
to substantive questions from the Medicines Registration Authority
depending on the solutions chosen for implementation
based on know-how from markets such as the US, Canada, and Portugal.
The Certis Pharma team has designed and managed world-class facilities, built skilled teams, implemented effective processes, conducted pioneering research in cannabis cultivation, achieved some of the highest yields in the industry, and won numerous awards for product quality.
We are well versed in current and future legal requirements and all the nuances and interpretations of guidelines related to the registration of pharmaceutical raw materials for the preparation of prescription drugs that are not described in the law, as well as in the realities of the functioning of registration institutions.
We are aware of all the problems that affect companies wishing to sell their products efficiently on the Polish market and we are committed to solving all those that may arise along the way, primarily related to:
We effectively guide our clients through the entire registration process. The company’s management attaches great importance to the team’s extensive experience, treating it as the key to gaining a competitive advantage and achieving highly specialized production goals – always with an emphasis on the highest quality.
A team of experts in the field of Polish pharmaceutical law
A pharmacist with twenty years of experience in the pharmaceutical industry.
For many years, a member of senior management within government administration, including the Ministry of Health, which is the central authority regulating the healthcare sector in Poland, as well as an inspection body responsible for the regulation of the entire pharmaceutical market in Poland.
A certified hospital pharmacy specialist, author of systemic solutions within the Polish healthcare system, including strategic reports and analyses for the Polish pharmaceutical market.
She possesses extensive competencies in regulatory, legal, and expert advisory areas within the pharmaceutical market.
She holds a Master of Business Administration (MBA) degree in healthcare management and has been decorated twice by two Ministers of Health, including a distinction for outstanding achievements for the Polish healthcare system and patients.
PhD in Chemistry, completed postgraduate studies qualifying her to serve as a European Qualified Person (QP).
She has over twenty years of experience in the pharmaceutical industry, encompassing operational and managerial roles in Quality Control, Quality Assurance, Research and Development, Project Delivery, and QP responsibilities. Since 2004, she has worked with a broad range of sterile and non-sterile dosage forms.
As a key member of project teams, she was responsible for preparing the quality sections of registration dossiers for generic medicinal products submitted under various European regulatory procedures: Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), and National Procedure (NP).
Thanks to her in-depth knowledge of GxP and GACP requirements as well as regulatory legislation, she effectively supports manufacturers in the preparation of quality sections of registration documentation. She is also an experienced author of technical articles for the pharmaceutical industry, explaining the complexity of European regulatory guidelines.
Since 2011, she has conducted numerous audits of manufacturers of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), intermediates, and packaging materials in Europe and Asia. In 2020, she began independent practice as a GMP Consultant and Auditor. She is currently undergoing training to qualify as a Pharmacovigilance (PV) Auditor.
Since 2020, she has been actively involved in the medical cannabis sector in Poland, where she was responsible for strategic planning, development, and full implementation of GMP standards in a newly established pharmaceutical manufacturing facility dedicated to hemp-based products. During this period, she was also responsible for the qualification and approval of cannabis products for registration purposes.
An experienced legal counsel holding a PhD in Law.
For over 13 years, he worked in the public sector (including the Ministry of Health and the Chief Pharmaceutical Inspectorate), holding managerial positions and focusing in particular on pharmaceutical law, including ensuring proper supervision and control over the manufacturing and distribution of medicinal products.
He has extensive experience in regulatory matters within the pharmaceutical market and the controlled substances market – including international and European Union law. He was also involved in drafting legislation and managing legislative processes. He completed a legislative apprenticeship at the Government Legislation Centre and was awarded by the Prime Minister with a badge of merit for contributions to legislation.
A specialist in cultivation technologies, law, and communication, actively engaged in education, regulation, and the development of the cannabis sector in Poland and the EU.
An employee of the Ministry of Agriculture and Rural Development (MRiRW) and agricultural research institutes, an academic lecturer, and a co-creator of educational programmes and innovative projects based on industrial hemp.
A co-founder and member of industry associations, actively involved in shaping cannabis policy. He strives for the integrated development of the sector, based on the highest standards, sustainability, and social responsibility.
The first professional in Poland to combine capital markets expertise with the medical cannabis industry. He has worked as a co-founder and CEO of numerous start-ups, particularly in innovative and highly regulated sectors.
He has advised both start-ups and public companies listed on the Warsaw Stock Exchange, including enterprises operating in the cannabis sector. He specialises in strategic planning, business development, and expansion into new markets. He also acts as a speaker and moderator at international conferences and industry events.
A team of internationally recognized experts (USA, Canada, Portugal)
A plant science specialist with extensive experience in regulated industries. After completing a Master’s degree in Genetic Engineering and Plant Biotechnology at Western University, she began her career in the Research and Development department of one of Canada’s largest food companies. There, she gained experience in quality assurance, regulatory affairs, and product development within facilities certified to GMP and HACCP standards.
In 2018, she entered the cannabis industry. As a tissue culture laboratory manager, she co-developed cannabis propagation protocols using tissue culture techniques and successfully implemented them in a production environment. She subsequently assumed the role of Director of Business Development and Operations Specialist at a commercial cannabis greenhouse spanning 1.3 million square feet in Ontario (Canada), further developing her expertise in cultivation and processing operations.
She is deeply involved in the development of quality assurance systems within the cannabis industry and in building a global cannabis supply chain.
She holds a Certified Pharmaceutical GMP Professional (CPGP) certification, is a trained auditor of pharmaceutical quality management systems compliant with GMP, and serves as Executive Director of the International Cannabis Quality Standards Association (ICQSA).
She frequently appears as a speaker at cannabis industry conferences and is also an instructor and developer of educational materials in the Cannabis Management program at the Academy of Applied Pharmaceutical Sciences in Toronto (Canada).
She operates professionally in Canada, Germany, and Thailand.
An internationally recognised cannabis market advisor with over a decade of hands-on experience in launching, scaling, and regulating international medical cannabis markets. Originally from Canada, he advises leading global pharmaceutical, tobacco, and consumer packaged goods (CPG) companies on international cannabis strategies.
He has played key roles in opening regulated cannabis markets across Europe, Australia, and other regions—including supporting the development of regulatory frameworks and commercial channels in Germany, the United Kingdom, Poland, Australia, and Israel.
He possesses deep expertise in evolving cannabis regulations, regulatory compliance, and engagement with national and supranational authorities such as BfArM (Germany), MHRA (United Kingdom), and TGA (Australia).
He has led sourcing and supply chain strategies for leading cannabis distributors and importers in these markets, ensuring uninterrupted access to GMP-compliant cannabinoid active substances, flower, and extract-based products. His work has directly supported patient access and client business growth in highly regulated pharmaceutical environments, as well as in emerging recreational cannabis markets.
His key areas of experience include:
– Advising and supporting licensed producers in Canada on export and distribution agreements with importers and pharmacies in the EU and Australia.
– Collaborating with global supply chain partners to source and deliver the highest-quality medical cannabis products to leading pharmacy networks in Germany and the United Kingdom.
– Supporting product registration, pharmacovigilance oversight, and market entry strategies for international companies operating in Poland, Israel, and the United Kingdom.
He also maintains active relationships with foreign investment promotion agencies and regulatory authorities to support clients in responsible and effective entry into new markets. He regularly contributes to industry thought leadership through speaking engagements at global conferences, moderating panel discussions, and publishing white papers.
Former Senior Cultivation Scientist at MedReleaf and Director of Applied Cultivation following the company’s acquisition by Aurora Cannabis.
Under his leadership, a team of several dozen scientists and assistants operating across multiple facilities collected data and conducted experiments that resulted in a significant increase in yields and improvement in production quality.
Previously, he also worked in the ornamental greenhouse industry and as a research assistant, conducting studies on the impacts of climate change. He holds a Bachelor’s and Master’s degree in Agriculture from the University of Bologna (Italy) and a PhD in Agroclimatology from Humboldt University of Berlin.
For several years, he served as Director of Cultivation, where he led efforts to develop industry-leading, award-winning cannabis cultivation practices delivering high quality and high yields.
Following the company’s acquisition by Aurora Cannabis, he led evaluation and optimisation programmes across all cultivation facilities in Canada and supported similar initiatives in South America and Europe.
In addition to his cannabis cultivation experience, he also possesses extensive expert knowledge in commercial plant production. He completed a Bachelor’s degree in Horticulture in Canada.
He earned the first PhD in North America with a specialization in indoor cannabis cultivation and subsequently led operations at one of the world’s first facilities dedicated to the development of cannabis cultivation techniques and systems.
He served as Director of Research and Development, managing a team of ten scientists and operators. He also provided expert commentary on cannabis production to numerous media outlets and the Government of Canada.
